Cleared Traditional

K002976 - RESPONSE ELECTROPHYSIOLOGY CATHETER

K002976 is the FDA 510(k) clearance for RESPONSE ELECTROPHYSIOLOGY CATHETER by St Jude Medical. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K002976 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
88d
Days
Class 2
Risk

K002976 is an FDA 510(k) clearance for the RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODE.... Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St Jude Medical devices

Submission Details

510(k) Number K002976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date December 22, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 97
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K002976.
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
K031161 · Biosense Webster, Inc. · Jul 2003
LIVESIRE ELECTROPHYSIOLOGY CATHETER
K022380 · St Jude Medical · Oct 2002
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · St Jude Medical · Jul 2001
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · Biosense Webster, Inc. · Aug 2000
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753 · Cordis Corp. · Apr 2000
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · C.R. Bard, Inc. · Nov 1999